1. Field of the Invention
The present invention relates generally to medical devices and methods of use thereof. Specifically, the present invention relates to medical devices used to create a seal around an incision for performing an end-to-side anastomosis procedure on the aorta or other blood vessel.
2. Description of the Related Art
Currently, the standard practice in performing a coronary artery bypass surgical procedure is to open the patient's chest, place the patient on a cardiopulmonary bypass (heart-lung) machine, stop the heart from beating, and then attach the coronary artery bypass graft(s) to the aorta and coronary arteries. The heart-lung machine is needed to maintain the blood circulation through the patient and to provide gas and heat exchange surfaces. Typically, the blood is cooled using the heart-lung machine to slow down the metabolism of the patient. Additionally, the blood is oxygenated and carbon dioxide is allowed to be released from the blood. The aorta is usually clamped proximal to the entrance point of the blood from the heart-lung machine.
There can be numerous complications with stopping the patient's heart and using a heart-lung machine. The heart-lung machine typically needs to be primed with blood. This is usually done with blood from a blood bank which can be contaminated with infectious agents such as the HIV virus. The heart-lung machine can lyse red blood cells and destroy platelets causing anemia or increasing the risk of hemorrhage. The clamping of the aorta can release plaque into the blood stream, which can cause a stroke or a peripheral vascular incident.
Another technique is to partially cross-clamp the aorta with a "U" shaped clamp such that a small blood tunnel is created and an area of blood stasis is created for making a proximal anastomosis site. This technique eliminates the heart-lung machine, but increases the risk of plaque releasing into the blood stream.
Thus, it is desirable to have a device and method that greatly reduces the risks associated with coronary artery bypass surgical procedures.